PDF(Pubmed)
Abstract：
BACKGROUND: Recent developments suggest that neurosteroids may achieve rapid antidepressant effects. As such, neurosteroidogenesis mediated by the translocator protein 18 kDa (TSPO) might constitute a promising option for the treatment of depression. Therefore, the current clinical trial aims to get the first evidence of whether TPSO ligands promote rapid antidepressant effects. Furthermore, we study which mechanisms of action, e.g., modulation of distinct neuronal networks, neurosteroidogenesis, endocrinological mechanisms, TSPO expression or microbiome composition, contribute to their putative antidepressant effects.
METHODS: This is a randomized, placebo-controlled, double-blind single-center trial of 2-week treatment with the TSPO ligand etifoxine versus placebo in depressive patients. Main eligibility criteria: male or female individuals aged 18 to 65 years with unipolar/bipolar depressive disorder with no other psychiatric main diagnosis or acute neurological/somatic disorder or drug/alcohol dependence during their lifetime. The primary endpoint is the time point at which 50% of the maximal effect has occurred (ET50) estimated by the scores of the Hamilton Depression Scale (HAMD-21). A total of 20 patients per group are needed to detect changes of therapeutic efficacy about 5% and changes of ET50 about 10% with a power of 70%. Assuming a drop-out rate of 10-20%, 50 patients will be randomized in total. The study will be conducted at the Department of Psychiatry and Psychotherapy of the University of Regensburg.
CONCLUSIONS: This study will provide a first proof-of-concept on the potential of the TSPO ligand etifoxine in the treatment of depressive disorders.
BACKGROUND: Clinical Trials Register (EudraCT number: 2021-006773-38 , registration date: 14 September 2022) and German Register of Clinical Studies (DRKS number: DRKS00031099 , registration date: 23 January 2023).
METHODS: This is a randomized, placebo-controlled, double-blind single-center trial of 2-week treatment with the TSPO ligand etifoxine versus placebo in depressive patients. Main eligibility criteria: male or female individuals aged 18 to 65 years with unipolar/bipolar depressive disorder with no other psychiatric main diagnosis or acute neurological/somatic disorder or drug/alcohol dependence during their lifetime. The primary endpoint is the time point at which 50% of the maximal effect has occurred (ET50) estimated by the scores of the Hamilton Depression Scale (HAMD-21). A total of 20 patients per group are needed to detect changes of therapeutic efficacy about 5% and changes of ET50 about 10% with a power of 70%. Assuming a drop-out rate of 10-20%, 50 patients will be randomized in total. The study will be conducted at the Department of Psychiatry and Psychotherapy of the University of Regensburg.
CONCLUSIONS: This study will provide a first proof-of-concept on the potential of the TSPO ligand etifoxine in the treatment of depressive disorders.
BACKGROUND: Clinical Trials Register (EudraCT number: 2021-006773-38 , registration date: 14 September 2022) and German Register of Clinical Studies (DRKS number: DRKS00031099 , registration date: 23 January 2023).
摘要：
背景：最近的发展表明，神经类固醇可以达到快速的抗抑郁作用。因此，由转运蛋白18kDa（TSPO）介导的神经类固醇生成可能是治疗抑郁症的有希望的选择。因此,目前的临床试验旨在获得TPSO配体是否促进快速抗抑郁作用的第一个证据.此外，我们研究哪些作用机制，例如，不同神经元网络的调制，神经类固醇生成，内分泌机制，TSPO表达或微生物组组成，有助于他们的抗抑郁作用。
方法：这是一个随机的，安慰剂对照,在抑郁症患者中使用TSPO配体依替福辛与安慰剂治疗2周的双盲单中心试验。主要资格标准：18至65岁的男性或女性患有单相/双相抑郁障碍，在其一生中没有其他精神病主要诊断或急性神经/躯体障碍或药物/酒精依赖。主要终点是通过汉密尔顿抑郁量表（HAMD-21）的评分估计的最大效果的50％（ET50）发生的时间点。每组总共需要20名患者以检测约5%的治疗功效变化和约10%的ET50变化,功效为70%。假设辍学率为10-20%，总共将随机分配50名患者。该研究将在雷根斯堡大学精神病学和心理治疗系进行。
结论：这项研究将首次证明TSPO配体依替福辛治疗抑郁症的潜力。
背景：临床试验注册（EudraCT编号：2021-006773-38，注册日期：2022年9月14日）和德国临床研究注册（DRKS编号：DRKS00031099，注册日期：2023年1月23日）。
方法：这是一个随机的，安慰剂对照,在抑郁症患者中使用TSPO配体依替福辛与安慰剂治疗2周的双盲单中心试验。主要资格标准：18至65岁的男性或女性患有单相/双相抑郁障碍，在其一生中没有其他精神病主要诊断或急性神经/躯体障碍或药物/酒精依赖。主要终点是通过汉密尔顿抑郁量表（HAMD-21）的评分估计的最大效果的50％（ET50）发生的时间点。每组总共需要20名患者以检测约5%的治疗功效变化和约10%的ET50变化,功效为70%。假设辍学率为10-20%，总共将随机分配50名患者。该研究将在雷根斯堡大学精神病学和心理治疗系进行。
结论：这项研究将首次证明TSPO配体依替福辛治疗抑郁症的潜力。
背景：临床试验注册（EudraCT编号：2021-006773-38，注册日期：2022年9月14日）和德国临床研究注册（DRKS编号：DRKS00031099，注册日期：2023年1月23日）。
